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All entities who participate in the 340B program are subject to an Office of Pharmacy Affairs (OPA) audit regardless of entity type, size or volume of transactions. For the last five years, HRSA’s OPA has been completing approximately 200 audits a year and
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On April 19, 2024—fourteen years after the Congressional deadline—the Health Resources and Services Administration published its final rule for the 340B Administrative Dispute Resolution process. Although HRSA restarted its stalled ADR rulemaking in 2020 after two 340B grantee organizations sued,
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